SAN DIEGO, April 12, 2016 /PRNewswire/ -- Arena
Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced favorable
results from its Phase 1b multiple-ascending dose clinical trial of
APD371, a highly selective and potent agonist of the cannabinoid 2
(CB2) receptor with potential utility in the treatment
of pain.
This randomized, double-blind, placebo-controlled Phase 1b
clinical trial enrolled 36 healthy adults to evaluate the safety,
tolerability and pharmacokinetics of multiple-ascending doses of
APD371. Cohorts of 12 subjects (9 active, 3 placebo) were
administered doses of 50 mg, 100 mg, or 200 mg of APD371 or placebo
three times daily for 10 days and, in connection with the
pharmacokinetic evaluation, one time on the 11th day.
The most common adverse events were headache and nausea. All
adverse events were classified as mild, and there were no serious
adverse events reported. There was one discontinuation in the
high-dose group due to an adverse event of mild thirst and
somnolence. Reductions in blood pressure and heart rate were
observed, but none were symptomatic or resulted in an adverse
event. Drug levels at all doses tested in the trial, including the
lowest dose, were well above those believed to be needed to
stimulate the CB2 receptor.
"The results of this trial substantiate data from our
single-ascending dose trial of APD371. In both trials, we achieved
dose-responsive exposure without dose-limiting adverse events
across the range studied," said William R.
Shanahan, Jr., M.D., Arena's Senior Vice President and Chief
Medical Officer. "Our scientists designed APD371 as a highly
selective, peripherally restricted, full agonist to provide pain
relief without psychotropic effects, loss of efficacy over time, or
the dependence, abuse potential or adverse event profile associated
with other pain treatments."
About
APD371
APD371, an orally available agonist of the CB2
receptor, is Arena's internally discovered investigational drug
candidate intended for the treatment of pain and potentially other
indications. With its high level of selectivity for the
CB2 receptor versus the CB1 receptor and its
high peripheral restriction observed in preclinical studies, APD371
is designed to provide pain relief without psychotropic effects.
Targeting the CB2 receptor may also avoid or reduce the
potential for the dependence or abuse associated with opioid drugs
or the adverse event profile associated with NSAIDs. Preclinical
efficacy with APD371 has been shown in animal models of
osteoarthritic and neuropathic pain.
About Arena Pharmaceuticals
Arena embraces the challenge of improving health by seeking to
bring innovative medicines targeting G protein-coupled receptors to
patients. Arena's focus is discovering, developing and
commercializing drugs to address unmet medical needs, and
BELVIQ® (lorcaserin HCl) is Arena's first internally
discovered drug approved for marketing. Arena's US operations are
located in San Diego, California,
and its operations outside of the United
States, including its commercial manufacturing facility, are
located in Zofingen, Switzerland.
For more information, visit Arena's website at
www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are
registered service marks of Arena Pharmaceuticals, Inc.
BELVIQ® is a registered trademark of Arena
Pharmaceuticals GmbH.
Forward-Looking Statements
Certain statements in this press release are forward-looking
statements that involve a number of risks and uncertainties. Such
forward-looking statements include statements about the therapeutic
indication, utility, safety, efficacy, selectivity, potency and
mechanism of action of APD371; the significance of results from
clinical trials and studies of APD371; the potential of APD371 and
targeting the CB2 receptor, including with respect to
the treatment of pain and other indications and avoiding or
reducing the potential for the dependence, abuse or adverse event
profile of other pain treatments; the dosage level needed to
stimulate the CB2 receptor; embracing the challenge of
improving health; seeking to bring innovative medicines to
patients; and Arena's focus, plans, goals, strategy, expectations,
research and development programs, and ability to discover and
develop compounds and commercialize drugs. For such statements,
Arena claims the protection of the Private Securities Litigation
Reform Act of 1995. Actual events or results may differ materially
from Arena's expectations. Factors that could cause actual results
to differ materially from the forward-looking statements include,
but are not limited to, the following: top-line results are not
comprehensive and are based on a preliminary analysis of then
available data, and findings and conclusions related to the trial
are subject to change following a more comprehensive review of the
data; APD371 may not provide the anticipated, intended or desired
results; APD371 may not be developed, approved for marketing or
commercialized for any disease or condition; having adequate funds
and other assets and their effective use; risks related to
commercializing BELVIQ or any future drug, including regulatory,
manufacturing, supply and marketing issues and their availability
and use; the risk that Arena's revenues are based in part on
estimates, judgment and accounting policies, and incorrect
estimates or disagreement regarding estimates or accounting
policies may result in changes to Arena's guidance or previously
reported results; the timing and outcome of regulatory review is
uncertain, and lorcaserin may not receive any additional marketing
approvals; regulatory decisions in one territory may impact other
regulatory decisions and Arena's business prospects; government and
commercial reimbursement and pricing decisions; risks related to
relying on collaborative arrangements; the timing and receipt of
payments and fees, if any, from collaborators; the entry into or
modification or termination of collaborative arrangements; the
timing, success and cost of Arena's research and development and
related strategy and decisions; results of clinical trials and
other studies are subject to different interpretations and may not
be predictive of future results; clinical trials and other studies
may not proceed at the time or in the manner expected or at all;
unexpected or unfavorable new data; nonclinical and clinical data
is voluminous and detailed, and regulatory agencies may interpret
or weigh the importance of data differently and reach different
conclusions than Arena or others, request additional information,
have additional recommendations or change their guidance or
requirements before or after approval; data and other information
related to any of Arena's research and development may not meet
regulatory requirements or otherwise be sufficient for (or Arena or
a collaborator may not pursue) further research and development,
regulatory review or approval or continued marketing; Arena's and
third parties' intellectual property rights; and satisfactory
resolution of litigation or other disagreements. Additional factors
that could cause actual results to differ materially from those
stated or implied by Arena's forward-looking statements are
disclosed in Arena's filings with the Securities and Exchange
Commission. These forward-looking statements represent Arena's
judgment as of the time of this release. Arena disclaims any intent
or obligation to update these forward-looking statements, other
than as may be required under applicable law.
Contact: Arena Pharmaceuticals,
Inc.
Craig M. Audet, Ph.D., Senior
Vice
President,
Operations & Head of Global Regulatory Affairs
caudet@arenapharm.com
858.453.7200, ext. 1612
www.arenapharm.com
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SOURCE Arena Pharmaceuticals, Inc.